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Rule2021-066792021-04-01

Electronic Import Entries; Technical Amendments

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is amending its electronic import entries regulation to correct the statutory citation in the sections of that regulation requiring submission of the Drug Registration Number for human drugs and for animal drugs. The present revisions are necessary to correct editorial errors and to ensure that the codified cites the correct section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The electronic import entries regulation provides that the Drug Registration Number, which must be submitted at the time of entry in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), is the unique facility identifier specified in the FD&C Act. This rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

Action & Dates

Action
Final rule; technical amendments.
Dates
This rule is effective April 1, 2021.
Effective Date
2021-04-01

CFR References

Topics

CosmeticsDrugsExportsFood labelingImportsLabelingReporting and recordkeeping requirements

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2016-N-1487] AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Final rule; technical amendments. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is amending its electronic import entries regulation to correct the statutory citation in the sections of that regulation requiring submission of the ( printed page 17060) Drug Registration Number for human drugs and for animal drugs. The present revisions are necessary to correct editorial errors and to ensure that the codified cites the correct section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The electronic import entries regulation provides that the Drug Registration Number, which must be submitted at the time of entry in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), is the unique facility identifier specified in the FD&C Act. This rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations. DATES: This rule is effective April 1, 2021. ADDRESSES: For access to the docket to read background documents or comments received, go to https://www.regulations.gov and insert the docket number found in brackets in the heading of t

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Related Documents

Other Federal Register documents from the same docket.

Full Document

Citation: 86 FR 17059

Electronic Import Entries; Technical Amendments — Federal Register 2021-06679 | Open Gov by Base